MRI Implant 03-2013 · 2016-07-11 · MRI IMPLANT TABLE EDITED MARCH 2013 Device 1.5 T C 3.0T C Comments and Guidelines Breast Tissue Expander No No • Adjustable breast tissue expanders

MRI IMPLANT TABLE EDITED MARCH 2013

Device 1.5

T C

3.0T

C

Comments and Guidelines

Aneurysm

Clip

Yes

C*

Yes

C* • Aneurysm clips made from ferromagnetic materials are contraindicated

for MR procedure, since excessive magnetically induced forces may displace

these clips, causing serious injury or death.

• By comparison aneurysm clips classified as non-ferromagnetic

(eg. Titanium alloy) have been tested and shown to be safe for patients

undergoing MR procedures at 1.5T or lower.

• All aneurysm clips must be checked and documented for MRI compatibility.

• Every aneurysm clip placed here at UCSF since 1985, is safe at both

1.5T and 3T. ( Sugita T2 aneurysm Clip, Yasargil Phynox aneurysm clip (FE),

Yasargil Titanium aneurysm clip (FT))

• Aneurysm clips places at an outside hospital, must have written documentation

stating the make, model, and date of insertion. This information must be reviewed

and confirmed for MRI compatibility before the patient is allowed in the scan room.

• Due to the increased artifacts generated by the 3 Tesla, the 1.5Tesla should be the

scanner of choice, unless specific high resolution imaging is needed and has been

approved by the radiologist.

http://www.mrisafety.com/safety_article.asp?subject=146

http://www.radiology.ucsf.edu/patient-care/patient-safety/mri

C*=Conditional, see comments


Device 1.5

T C

3.0T

C


Breast

Tissue

Expander

No No • Adjustable breast tissue expanders and mammary implants are utilized for breast reconstruction following mastectomy, for the correction of breast and chest-wall deformities

and underdevelopment, for tissue defect procedures, and for cosmetic augmentation. These

devices are typically equipped with either an integral injection site or a remote injection

dome • it is recommended that a patient with a breast tissue expander that has a metallic

component be identified prior to MRI so that the radiologist is aware of the potential

problems related to the generation of artifacts as well as a possible injury.

• There are various breast tissue expanders that have magnetic ports to allow for a more

accurate detection of the injection site. These devices are substantially attracted to the

static magnetic fields of MR systems and, therefore, may be uncomfortable, injurious, or

contraindicated for patients undergoing MR procedures.

• Expanders which are unsafe for MRI include the following expanders:

Contour Profile Tissue Expander

McGhan Medical Breast Tissue Expander

Magna-Site Tissue Expander



Cardiac

Loop

Recorder

Yes

C*

Yes

C*

Reveal Plus (Model # 9526) Insert able Loop Recorder (ILR)

Magnetic and Radio Frequency (RF) fields produced by MRI may adversely affect the data being

stored by the Reveal Plus Insert able Loop Recorder (ILR).

Since the ILR contains ferromagnetic components, the strong magnetic field of the MRI system

may apply a mechanical force on the ILR. The patient may be able to feel this magnetic force on

the ILR. While this does not represent a safety hazard, the patient should be made aware of this

possibility to avoid undue patient concern.

Reveal DX (Model # 9528) and Reveal XT (Model # 9529) Insert able Cardiac Monitor

Non-clinical testing demonstrates that Reveal DX and Reveal XT devices are safe for use in the

MRI environment when used according to these instructions.

The Reveal DX and Reveal XT can be safely scanned in patients under the following conditions:


MRI Equipment Requirements

• The MRI equipment must be a closed bore, cylindrical magnet with a static magnetic field

of 1.5 Tesla (T) or 3.0 T.

• MRI equipment must be used in normal operating mode (based on standards defined in

IEC 60601-2-33). Refer to Reveal DX or Reveal XT Clinician Manual for additional

information.

• If local or surface coils are needed, please refer to the Reveal DX or Reveal XT Clinician

Manual for additional information.

MRI Procedural Requirements

• Verify that the Reveal DX or the Reveal XT is at least 6 weeks post-implant. This

waiting period allows sufficient time for implant pocket and wound healing and minimizes

the effects of device “tugging” caused by the magnetic fields.

• Verify that the Reveal DX or Reveal XT implant location is in the subcutaneous tissue of

the chest region.

• Uninterrupted duration of active scanning (when RF and gradients are on) over the chest

during MRI must not exceed 30 minutes. A waiting period of at least 10 minutes is required

if additional chest scans are necessary.

• Check that additional implantable devices are not present, including abandoned pacing leads.

• Medtronic has not tested interactions with all other implanted devices or abandoned pacing leads.

• The MRI procedure may overwrite the recorded data in the Reveal DX or the Reveal XT. Print

or save the data stored in the Reveal DX or Reveal XT to diskette before the MRI.


• The Patient Assistant and the Medtronic CareLink Model 2090 Programmer are not MRI safe

and should not be brought into MRI controlled room (magnet room). Continued below…….

Post-MRI operation

• Check the programmed parameters of the Reveal DX or the Reveal XT after the MRI

procedure.

• Print or save the data collected during the MRI procedure to diskette because the MRI procedure

may temporarily affect the Reveal DX or the Reveal XT’s event detection and recording. The date

and time of the MRI procedure should be recorded under the Patient icon in the notes section for

future reference. Note: The Cardiac Compass trend data cannot be cleared and might show

irregularities at the time of the MRI operation.

www.mrisafety.com/safety_info.asp

Device 1.5

T C

3.0T

C


Cardiac

Pacemaker

Yes

C*

No The following guidelines have been set here at UCSF to scan a patient with a pacemaker or ICD:

• A risk- benefit ratio must be established and benefit from the MRI examination


should clearly outweigh the risks of the procedure.

• MR imaging in the thoracic region is subject to additional risk and this

should be considered when evaluating the benefit to risk for a specific patient.

• Multiple MR exams in a single patient should also be avoided, as there is potential

for increased risk and this should needs to be considered when determining if the

benefits clearly outweigh the risks.

• The study should not be performed if similar clinical information could be

obtained by a different image modality

• The MRI scan must be approved by an attending radiologist and an

electro-physiologist.

• For Pacemaker patients: The patient must be non-pacemaker dependent.

• For ICD patients: Risks associated with MR examination in patients with ICD

are expected to be higher than in patients with pacemakers. Therefore,

MR examination of patients with ICDs should not be performed unless there

are highly compelling circumstances and when the benefits clearly outweigh

the risks. ICD patients must be non-pacemaker dependent.

• The patient must have the pacemaker/ ICD in place for more than 6 weeks.

• The patient must be not at or near Elective Replacement Indicator (ERI).

• Abandoned temporary epicardial (cut at skin) leads are not a contraindication

for MRI (please see images a. and b. bellow). Abandoned/capped trans venous

leads are a contraindication to MRI (please see image c. bellow).


c.


• Prior to the scan date, a cardiology consult must be scheduled, where it will be determined if the

pacemaker/ICD patient is safe to have an MRI. At this time, a written informed consent will be

established. If a patient is referred from and outside physician, a visit to the UCSF device clinic

should be scheduled before the MRI is acquired.

• An electro-physiologist, or cardiologist or device nurse (with pacemaker/ICD monitoring

experience) must be present before, during, and after the MRI exam to validate the performance

integrity of the pacemaker/ICD prior to the MRI exam, monitor the patient during the exam, and

check the pacemaker/ICD performance after the exam. An electro-physiologist should be

carrying a pager and be within quick reach of the MRI scanner during the entire examination. For

patients with ICDs, a physician with electrophysiological expertise should perform post scan

device reprogramming and defibrillation threshold testing. Arrangements should be made for the

patient to follow-up with electro physiologist at 3 months after the MRI.

• The patient should be monitored continuously during the MR procedure (e.g., blood pressure,

pulse rate, oxygen saturation, and ECG).

• Appropriate personnel, a crash cart, and defibrillator must be available throughout the procedure

to address an adverse event.

• Maintain visual and voice contact throughout the procedure with the patient.

• The patients must be able to communicate in case any complications arise.

• Instruct the patient to alert the MR system operator of any unusual sensations or problems so

that, if necessary, the MR system operator can immediately terminate the procedure.

• The patients will only be scanned during normal workday hours (8A-5P) on 1.5T scanners, only

in hospital setting with appropriate trained personnel. For urgent, on-call cases, scans may need


to be done after 5P or on weekends, although it is preferable to wait until normal workday hours

if possible.

• The MRI will only be scheduled during the day and appointments will be coordinated to ensure

that an MRI physicist and an attending radiologist are involved to tailor the study for minimum

SAR while obtaining the essential clinical information.

• Patients with MR conditional Medtronic pacemaker (Revo MRI SureScan pacing system) can

undergo an MRI study only if the MR isocenter is superior to the C1 vertebra or inferior to the

T12 vertebra. In that case, Medtronic specific guidelines should be followed. In case MR

isocenter is contained between C1 and T12, specific MR safety protocols described above should

be followed.

• The current protocol is effective now for cardiac imaging and neuroimaging studies. Additional

clinical indications will be considered in the future.


http://www.radiology.ucsf.edu/patient-care/patient-safety/mri

http://www.medtronic.com/for-healthcare-professionals/products-therapies/cardiac-rhythm/pacemakers/revo-

mri-pacing-system/index.htm

C*=Conditional, see comments


Device

1.5

T C

3.0T

C


Cochlear

Implants

No No Some types of cochlear implants employ a relatively strong cobalt samarium magnet used in conjunction

with an external magnet to align and retain a radio frequency transmitter coil. Other types of cochlear

implants are electronically activated. Consequently, MR procedures are strictly contraindicated in

patients with these types of implants because of the possibility of injuring the patient and/or damaging or

altering the function of the cochlear implants.

Device 1.5

T C

3.0T

C


Deep Brain

Stimulator

(DBS)

Yes

C*

No • Deep brain stimulation (DBS) is a surgical procedure used to treat a variety

of disabling neurological symptoms—most commonly the debilitating symptoms

of Parkinson’s disease.

• The DBS system consists of three components: the lead, the extension, and the

neurostimulator. The neurostimulator (the "battery pack") is usually implanted

under the skin near the collarbone. In some cases it may be implanted lower in

the chest or under the skin over the abdomen.

• The greatest concern for electronically activated or electrically conductive implants

in the brain is excessive MR imaging-related heating, which can cause irreversible

tissue damage.

• This may lead serious injury to the patient, including the possibility of transient

dystonia, paralysis, coma, or even death.

• The Deep brain stimulator must turn off and checked before the exam, and turned


on and checked after the exam. The primary contact is Monica Volz, Pg 443-5493.

• Patients with DBS implants can have MRI imaging of the brain with a head coil

(transmit-receive head coil, where the RF is not transmitted by the body coil

• Imaging of parts of the body other than the head is prohibited.

http://www.medtronic.com/your-health/parkinsons-disease/therapy/our-dbs-therapy-products/activa-

rc/index.htm


Device

1.5

T C

3.0T

C

C* = Conditional, see comments


Drug

Infusion

Pump

Yes

C* No A drug infusion pump is used for automatic delivery of antineoplastic agents, morphine, or narcotics.

The infusion pump has a motor that may have ferromagnetic properties, a magnetic switch, and is

programmed by telemetry. Potential issues pertaining to MRI imaging of patients with a drug infusion

pump include the following:

1) Stopping of needed medication

2) Temporary or permanent stall of the motor

3) Local tissue heating adjacent to implant during imaging

4) Increase potential for Peripheral nerve stimulation (PNS)

Although many drug infusion pumps are contraindicated for MRI, there are currently some pumps that

can be exposed to the MRI environment during imaging under strict conditional requirements. Always

review the manufacturer guidelines for the specific pump before introducing the patient into the

magnet room and proceeding with the exam. Strictly adhere to the manufacturer’s conditional

requirements for managing the pump prior to, during, and post imaging. The following are

examples of conditional drug infusion pumps:

AccuRx Constant Flow Implantable Pump (St. Jude Medical, Plano, TX)www.sjm.com

SynchroMed (II,EL) , implantable drug infusion device (Medtronic Inc.)http://www.medtronic.com


Device 1.5

T C

3.0T

C



External

Ventricular

Drain

Yes Yes • An external ventricular drain (EVD) is a device used in neurosurgery that relieves raised

intracranial pressure and monitors CSF fluid levels.

• The EVDs utilized here at UCSF is the Integra Limitorr, and the Integra MoniTorr.

• Both are safe to use on either the 1.5 or 3.0T. This device does not cause artifacts.

http://www.integra-ls.com//PDFs/NeuroCriticalCare/Limitorr%20Sales%20Brochure.pdf

Device 1.5

T C

3.0T

C


Integra

Camino

Bolt

No No • Camino Bolt catheter is an intracranial pressure monitoring device. It consists of a cranial bolt

surgically implanted into the skull in which a pressure transducer is placed. At the end of the

pressure transducer is a transducer connector, which is attached to a cable that is attached to a

monitor.

• The Camino Bolts utilized here at UCSF is made by Integra Neurosciences. Currently, the FDA


has requested that Integra revalidate their results concerning the Camino Bolt and its MR

compatibility. Until such time that the manufacturer has completed their revalidation process and

can produce a document that states that Camino Bolt and the various models are MRI safe in a

1.5T and or a 3.0T MR environment, Camino Bolts will be contraindicated for both the 1.5T and

3.0T.

www.integra-ls.com/PDFs/Camino/Camino%20110-4HM%20PI.PDF

Device 1.5

T C

3.0T

C


InterStim

Therapy

Yes

C*

No • InterStim Therapy is similar to a pacemaker for the bladder. The implantable device uses mild

electrical pulses to target the communication problem that exists between the sacral nerves and

the brain to tell the bladder to work correctly.

• The therapy treats urinary retention and the symptoms of overactive bladder, including urinary

urge incontinence and significant symptoms of urgency-frequency.

• As with any neurostimulator, only the brain can be imaged using a transmit-receive head coil.


http://professional.medtronic.com/pt/uro/snm/prod/interstim/manuals-technical-

resources/index.htm


Device 1.5

T C

3.0T

C


Linux

Reflux

Manageme

nt

System

No No • Consists of a series of titanium beads, each with a magnetic core, connected together with

titanium wires to form a ring shape. It is implanted around the lower end of the

esophagus to help control gastro esophageal reflux (GERD).

• Patients who have the LINX device should not be exposed to , or undergo, an MRI.

Exposure to MRI could cause serious injury to the patient and the device may damaged.

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Re

cently-ApprovedDevices/ucm300790.htm


Device

1.5

T C

3.0T

C



Magnimplant

Magnatract

Sternum

Implant

No No Magnimplant” and “Magnatract”in a combined system to correct for pectus excavatum or sunken chest

deformity, in pediatric patients. As part of the system “Magnimplant” is an internal magnet that is

surgically placed behind the sternum, and “Magnatract” is an external brace with a magnet implanted.

The devices combine to exert a defined magnetic force to the chest wall.

This device system is totally contraindicated for MRI at any field strength.


Device 1.5

T C

3.0

T C


Programmable

Ventricular

Shunt

Yes

C*

Yes

C*

Programmable Valves are implantable devices that provide constant

Intra-ventricular pressure and drainage of CSF for the management of hydrocephalus.

• Subjecting the valve to strong magnetic fields may change the setting of the valve(shunt)

The use of Magnetic Resonance (MR) systems up to 3-Tesla will

not damage the valve mechanism, but may change the setting of the valve. Confirm the

valve setting after an MRI procedure.

• The performance level setting should always be checked before and after MRI exposure. Contacts to check shunt: Pedi – Carolyn 443-4726, Adult – Gwen 443-

4769

• The following programmable shunts have been approved for the 3.0 Tesla MRI: Codman Hakim (Johnson and Johnson), Delta Shunt (Medtronics),proGAV

programmable valve (Aesculap), Pulsar Valve (Sophysa USA), Strata

(Medtronics), Sophy Adjustable pressure valve (Sophysa USA)

• Due to the increased artifacts generated by the 3 Tesla, the 1.5Tesla should

be the scanner of choice, unless specific high resolution imaging is needed and has been

approved by the radiologist.

•



Device 1.5

T C

3.0

T C


Vagus

Nerve

Stimulator

Yes

C*

Yes

C* • The VNS Therapy generator is an implantable, programmable pulse generator that delivers a

precise pattern of stimulation to the left vagus nerve.

• MRI procedures should not be performed on patients

with VNS Therapy Systems who have a Lead break. A broken Lead

should be removed prior to MRI. Suspected Lead breaks should be

confirmed by performing appropriate diagnostic procedures and

consultation with Cyberonics. Broken Lead wires present increased

risk of thermal injury to patients during MRI procedures

• Magnetic resonance imaging (MRI) should not be performed with a magnetic resonance body

coil in the transmit mode. The heat induced in the Lead by an MRI body scan can cause injury.

• Imaging restricted to brain or head imaging utilizing a transmit-receive head coil.

• The device must be turned off (Pulse generator output programmed to 0.0 mA) prior to the exam

and the device checked and reset after the exam. See below.


http://us.cyberonics.com/en/vns-therapy/healthcare-professionals/manuals/


•

Documents

MRI Implant 03-2013 · 2016-07-11 · MRI IMPLANT TABLE EDITED MARCH 2013 Device 1.5 T C 3.0T C Comments and Guidelines Breast Tissue Expander No No • Adjustable breast tissue expanders